Label: SSKI- potassium iodide solution

  • NDC Code(s): 0245-0003-08, 0245-0003-31
  • Packager: Upsher-Smith Laboratories, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated October 12, 2017

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  • Description

    SSKI® (potassium iodide oral solution, USP) is a saturated solution of potassium iodide containing 1 gram of potassium iodide per mL.

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  • Clinical Pharmacology

    Potassium iodide is thought to act as an expectorant by increasing respiratory tract secretions and thereby decreasing the viscosity of mucus.

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  • Indications and Usage

    SSKI® (potassium iodide oral solution, USP) is for use as an expectorant in the symptomatic treatment of chronic pulmonary diseases where tenacious mucus complicates the problem, including bronchial asthma, bronchitis and pulmonary emphysema.

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  • Contraindications

    Contraindicated in patients with a known sensitivity to iodides.

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  • Warnings

    Potassium iodide can cause fetal harm, abnormal thyroid function, and goiter when administered to a pregnant woman. Because of the possible development of fetal goiter, if the drug is used during pregnancy or if the patient becomes pregnant during therapy, apprise the patient of the potential hazard.

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  • Precautions

    General

    In some patients, prolonged use of iodides can lead to hypothyroidism. Iodides should be used with caution in patients having Addison's disease, cardiac disease, hyperthyroidism, myotonia congenita, tuberculosis, acute bronchitis, or renal function impairment.

    Drug Interactions

    Concurrent use with lithium or antithyroid drugs may potentiate the hypothyroid and goitrogenic effects of these medications. Concurrent use with potassium-containing medications, potassium-sparing diuretics and angiotensin-converting enzyme inhibitors (ACE inhibitors) may result in hyperkalemia and cardiac arrhythmias or cardiac arrest.

    Drug/Laboratory Test Interactions

    Thyroid function tests may be altered by iodide.

    Pregnancy

    Category D

    see "Warnings" section.

    Nursing Mothers

    Potassium iodide is excreted in breast milk. Use by nursing mothers may cause skin rash and thyroid suppression in the infant.

    Pediatric Use

    Safety and effectiveness in children have not been established.

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  • Adverse Reactions

    The most frequent adverse reactions to potassium iodide are stomach upset, diarrhea, nausea, vomiting, stomach pain, skin rash, and salivary gland swelling or tenderness. Less frequent adverse reactions include gastrointestinal bleeding, confusion, irregular heartbeat, numbness, tingling, pain or weakness in hands or feet, unusual tiredness, weakness or heaviness of legs, fever, and swelling of neck or throat. Thyroid adenoma, goiter, and myxedema are possible side effects.

    Iodism or chronic iodine poisoning may occur during prolonged treatment or with the use of high doses. The symptoms of iodism include burning of mouth or throat, severe headache, metallic taste, soreness of teeth and gums, symptoms of head cold, irritation of the eyes with swelling of the eyelids, unusual increase in salivation, acneform skin lesions in the seborrheic areas, and rarely, severe skin eruptions. If symptoms of iodism appear, the drug should be withdrawn and the patient given appropriate supportive therapy.

    Hypersensitivity to iodides may occur and may be manifested by angioedema, cutaneous and mucosal hemorrhage, and signs and symptoms resembling serum sickness, such as fever, arthralgia, lymph node enlargement, and eosinophilia.

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  • Overdosage

    Acute toxicity from potassium iodide is relatively rare. An occasional individual may show marked sensitivity and the onset of acute poisoning can occur immediately or hours after administration. Angioedema, laryngeal edema and cutaneous hemorrhages may occur.

    Iodism or chronic iodine poisoning may occur during prolonged treatment or with the use of high doses. Symptoms of iodism typically disappear soon after discontinuation of the drug. Abundant fluid and salt intake aids in iodide elimination.

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  • Dosage and Administration

    Adults - 0.3 ml (300 mg) or 0.6 ml (600 mg) diluted in one glassful of water, fruit juice or milk 3 to 4 times daily. To minimize gastric irritation, take with food or milk.

    This medication should be used no longer than necessary to produce the desired effect.

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  • How Supplied

    SSKI® (potassium iodide oral solution, USP) is supplied in 1 fluid ounce (30 ml) bottles (NDC 0245-0003-31) with a calibrated dropper marked to deliver 0.3 ml (300 mg) and 0.6 ml (600 mg); and 8 fluid ounce (237 ml) bottles (NDC 0245-0003-08). Inactive ingredient: Sodium thiosulfate as a preservative.

    Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed and protected from light.

    Dispense in tight, light-resistant containers with child-resistant closures.

    Notice: When exposed to cold temperatures, crystallization may occur, but on warming and shaking, the crystals will redissolve. If the solution turns brownish-yellow in color, it should be discarded.

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  • SPL UNCLASSIFIED SECTION

    Manufactured by
    UPSHER-SMITH LABORATORIES, LLC
    Maple Grove, MN 55369

    Revised 0917

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  • PRINCIPAL DISPLAY PANEL - 1 g/mL Bottle Label

    NDC 0245-0003-31

    SSKI®

    Potassium Iodide
    Oral Solution, USP
    (saturated)

    1 g/mL

    1 Fluid Oz (30 mL)
    Rx only

    UPSHER-SMITH

    PRINCIPAL DISPLAY PANEL - 1 g/mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    SSKI 
    potassium iodide solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0245-0003
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Potassium Iodide (UNII: 1C4QK22F9J) (Iodide Ion - UNII:09G4I6V86Q) Potassium Iodide 1 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    sodium thiosulfate (UNII: HX1032V43M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0245-0003-31 1 in 1 CARTON 04/30/1973
    1 30 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    2 NDC:0245-0003-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/30/1973
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 04/30/1973
    Labeler - Upsher-Smith Laboratories, LLC (047251004)
    Establishment
    Name Address ID/FEI Business Operations
    Upsher-Smith Laboratories, LLC 079111820 MANUFACTURE(0245-0003)
    Establishment
    Name Address ID/FEI Business Operations
    Upsher-Smith Laboratories, LLC 047251004 ANALYSIS(0245-0003)
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